Label: BIORE- salicyclic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2025

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses •For the treatment of acne

  • WARNINGS

    Warnings

    For external use only.

    Flammable: Keep away from fire or flame

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • avoid contact with eyes. If contact occurs, rinse thoroughly with water

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse skin thoroughly before applying medication.
    • Cover the entire affected area with a thin layer 1 to 3 times daily using a cotton ball or pad.
    • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, alcohol denat., isopropyl alcohol, hamamelis virginiana (witch hazel) water, glycerin, polysorbate 20, sodium hydroxide, sodium citrate, alcohol, citric acid, tetrasodium glutamate diacetate

  • QUESTIONS

    Questions? 1-888-BIORE-11

  • PRINCIPAL DISPLAY PANEL

    Biore

    CLEAR & BREATHABLE

    WITCH HAZEL 2% BHA TONER

    Salicylic Acid Acne Treatment

    Questions? 1-888-BIORE-11 biore.com

    BIORE is a trademark of Kao Corp.

    Distributed by Kao USA Inc.,

    Cincinnati, OH 45214 ©2022

    Made in Canada

    label

  • INGREDIENTS AND APPEARANCE
    BIORE 
    salicyclic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-196
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-196-80235 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/13/2023
    Labeler - KAO USA (004251617)
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